Vulnerability and Risk of Neuropathic Pain in Cancer (CANOPY)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Neuropathic Pain; Predictive; Cancer

Treatments: Other: Cognitive-emotional and pain assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT06511674

RBHP 2023 PICKERING

Details and patient eligibility

About

Successive and repeated therapeutic interventions during cancer management - surgery, chemotherapy, radiotherapy - can all, to varying degrees, generate acute pain, central pain sensitization and chronic pain. Almost 58% of patients suffer from chronic pain, often of the neuropathic type, with altered quality of life and disease burden amplified by difficulty in achieving effective relief.

Indeed, neuropathic pain in cancer remains difficult to treat, often arrives insidiously, may persist well beyond cancer remission, and frequently has a fate that is difficult to predict. Current treatments for neuropathic pain are based on the recommendations of learned societies, but therapeutic failures are frequent, and iatrogenic pathology is high. Many factors have been identified as being associated with the development of chronic pain in cancer patients. The intensity of preoperative pain, opioid consumption, age, sleep disorders, cognitive-emotional state, psychological vulnerability and social precariousness are all factors that influence and perpetuate chronic pain linked to cancer and its management. Several studies have shown that 6 months or 1 year after cancer diagnosis, there are various pain trajectories, enabling us to identify several pain patient phenotypes. The patient's overall state of vulnerability at the time of cancer diagnosis has an impact on the trajectory of pain chronicisation, and it is often difficult for clinicians to apprehend this risk. In practice, we lack a validated, easy-to-use tool that would enable us to predict the risk of pain chronicisation for each patient, even before the start of the treatment process.

Enrollment: 625 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Patients:

• Patient over 18 years of age,
• Patient suffering from cancer (breast, gynecological, colorectal, lung) and having to undergo one or more anti-cancer therapeutic procedures (chemotherapy, surgery, hormonal therapy, radiotherapy, targeted therapy, etc.),
• Sufficient cooperation and understanding to comply with the study requirements,
• Agreement to give oral consent for the study,
• Affiliation with the French Social Security system.

Exclusion Criteria Patients:

• History of cancer and anti-cancer therapy (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy, etc.),
• History and/or presence of primary brain tumors (glioblastoma, meningioma, neurofibroma, etc.) ),
• History of neurological disorders (Parkinson's disease, Alzheimer's disease, dementia, epilepsy, moderate to severe head trauma, etc.),
• Medical and/or surgical history judged by the investigator or his representative to be incompatible with the study,
• Subject whose cooperation and understanding do not allow strict compliance with the conditions laid down in the protocol,
• Pregnant or breast-feeding women,
• Beneficiary of a legal protection measure.

Inclusion Criteria Healthy Volunteers:

• Subject over 18 years of age,
• Subject free of any treatment in the 7 days preceding inclusion, in particular no use of analgesics, or judged by the investigator or his representative to be compatible with the study
• Subject with no history of cancer,
• Subject considered to be in good health by the investigator,
• Sufficient cooperation and understanding to comply with the study requirements,
• Agreement to give oral consent to the study,
• Affiliation with the French Social Security system,

Exclusion Criteria Healthy Volunteers:

• Subjects with a medical and/or surgical history judged by the investigator or his representative to be incompatible with the trial,
• Subjects whose cooperation and understanding do not allow strict compliance with the conditions laid down in the protocol,
• Pregnant or breast-feeding woman,
• Participating in another clinical trial, or within the exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial,
• Benefiting from a legal protection measure.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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625 participants in 2 patient groups

Cancer patients

Experimental group

Description:

500 cancer patients: 100 women with breast cancer, 100 women with gynecological cancer, 150 patients with lung cancer (100 men, 50 women) and 150 patients with colorectal cancer (100 men, 50 women).

Treatment:

Other: Cognitive-emotional and pain assessments

Healthy volunteers controls

Experimental group

Description:

125 healthy control volunteers from the volunteer database

Treatment:

Other: Cognitive-emotional and pain assessments